RCT of Mantram Repetition Versus Health Education for Veterans With PTSD and Chronic Pain

Part of paid clinical trials in San Diego, California.

Sponsor
VA Office of Research and Development
Study ID
NCT07725588
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Pain, Chronic
  • Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mantram Repetition Program for PTSD + Pain — BEHAVIORAL
    manualized Mantram Repetition Program adapted for Veterans with PTSD and chronic pain
  • Health Education while Living with Pain — BEHAVIORAL
    manualized health and wellness psychoeducation and discussion group

Study Details

Approximately 450,000 Veterans Health Administration service users have both posttraumatic stress disorder (PTSD) and chronic pain (CP); treatments that efficiently target both PTSD and CP are limited, and new interventions should address the unique needs of Veterans with PTSD/CP. Mantram Repetition Program (MRP), a meditation-based program, appears well-suited to address these high-priority VA needs. MRP has established effectiveness for treatment of PTSD, is broadly acceptable, can be learned quickly and applied flexibly. However, rigorous testing is needed for pain-related outcomes among a PTSD/CP population. The proposed study will include a randomized controlled trial comparing the efficacy of MRP for PTSD/CP to Health Education while Living with Pain among a sample of 170 Veterans with comorbid PTSD/CP. The primary outcomes will be PTSD symptoms and pain interference. Results from this study will directly inform patient care among the nearly 4% of Veterans with PTSD/CP.

Key Dates

First listed
Jul 24, 2026
Start date
Apr 1, 2027
Status verified
Jul 2026
Primary completion
Apr 1, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: mantram repetition program
    8-session group-based meditation training class led by a trained instructor
  • Active Comparator: health education
    8-session group-based health education and discussion led by a trained instructor

Primary Outcome Measure

The Revised Clinician-Administered PTSD scale for DSM-5 (CAPS-5-R) [ Time Frame: 0, 5, 10, 20 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare System, San Diego, CASan DiegoCalifornia92161-0002
Anne L Malaktaris
[email protected]
858-642-3794
Anne L Malaktaris (PRINCIPAL_INVESTIGATOR)

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By research site
VA San Diego Healthcare System, San Diego, CA· San Diego, CA

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